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Alzamend Neuro, Inc. (ALZN)·Q3 2023 Earnings Summary

Executive Summary

  • Alzamend posted no revenue, and Q3 2023 loss widened on higher R&D tied to AL001 Phase IIA and ALZN002 IND-related work; net loss was $5.43M ($0.06 per share), versus $3.11M ($0.03) in Q2 and $3.04M ($0.03) in Q1 .
  • Cash declined to $7.38M, down from $9.18M (Q2) and $11.53M (Q1), reflecting increased clinical spending; working capital reported at $5.8M in the Q3 press release .
  • Management highlighted two near-term clinical catalysts: completion of the clinical portion of AL001 Phase IIA (topline data expected June 2023) and initiation of ALZN002 Phase I/IIA in March 2023 .
  • CFO pointed to a potential non-dilutive liquidity event: $14.8M note receivable anticipated by Dec 31, 2023 (not assured), potentially funding INDs and Phase II programs beyond AL001/ALZN002 .

What Went Well and What Went Wrong

What Went Well

  • Completed clinical portion of AL001 Phase IIA; topline data expected June 2023. “We strongly believe that AL001’s patented ionic cocrystal technology could potentially provide clinicians with a major improvement...” (CEO) .
  • Clear near-term clinical execution plan: ALZN002 Phase I/IIA initiation targeted for March 2023 (mild–moderate Alzheimer’s), enabling dose selection for a larger Phase IIB .
  • Liquidity optionality: management highlighted expected $14.8M non-dilutive note receivable by year-end 2023 to support additional INDs and Phase II trials (bipolar, MDD, PTSD), if received (CFO) .

What Went Wrong

  • Operating expenses rose materially; Q3 R&D reached $2.89M vs. $1.53M (Q2) and $1.38M (Q1) on clinical activity, pressuring losses .
  • G&A remained elevated (Q3: $2.53M), reflecting stock-based comp and marketing/professional fees across recent periods .
  • No product revenue and continued cash burn; cash fell to $7.38M by Q3, down sequentially from $9.18M and $11.53M .

Financial Results

MetricQ1 2023 (3mo ended Jul 31, 2022)Q2 2023 (3mo ended Oct 31, 2022)Q3 2023 (3mo ended Jan 31, 2023)
Revenue ($USD)$0 $0 $0
Basic & Diluted EPS ($)$(0.03) $(0.03) $(0.06)
Net Loss ($USD)$(3,037,074) $(3,109,991) $(5,425,574)
R&D Expense ($USD)$1,375,953 $1,532,985 $2,888,847
G&A Expense ($USD)$1,659,589 $1,573,418 $2,534,665
Total Operating Expenses ($USD)$3,035,542 $3,106,403 $5,423,512
Cash and Equivalents ($USD, period end)$11,527,121 $9,182,812 $7,375,841

KPIs

KPIQ1 2023Q2 2023Q3 2023
Accounts Payable & Accrued Liabilities ($USD)$1,028,700 $648,119 $2,642,473
Working Capital ($USD)n/an/a$5,800,000 (press release figure)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
AL001 Phase IIA topline data timingJune 2023Not previously datedTopline data expected in June 2023 New/Specified
ALZN002 Phase I/IIA trial startMarch 2023IND cleared Oct 2022; initiation pendingInitiation expected March 2023 New/Specified
Liquidity – note receivableDec 31, 2023 maturityPrior financing disclosures$14.8M expected (not assured) by Dec 31, 2023 Reiterated timing/amount

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2023)Previous Mentions (Q2 2023)Current Period (Q3 2023)Trend
AL001 clinical executionPhase IIA MAD underway; plan to define MTD and advance (Q1 MD&A) Ongoing Phase IIA; healthy cohort added; continued monitoring (Q2 MD&A) Clinical portion completed; topline data expected June 2023 (PR) Progressing to data readout
ALZN002 developmentPre-IND/IND planning; combined Phase I/II strategy (Q1 MD&A) IND submitted Sep 2022; FDA “study may proceed” Oct 31, 2022 (Q2 MD&A) Phase I/IIA initiation targeted March 2023 (PR) Advancing to first dosing
Liquidity strategyCash $11.5M; funding needs recognized (Q1 BS/MD&A) Cash $9.18M; continued funding needs (Q2 BS/MD&A) Cash $7.38M; working capital $5.8M; potential $14.8M non-dilutive receivable by year-end (PR) Cash declining; optionality via receivable
R&D spend cadenceR&D $1.38M (Q1) driven by AL001/ALZN002 prep R&D $1.53M (Q2), higher professional/clinical fees R&D $2.89M (Q3), reflecting Phase IIA and IND-related activities Rising with trial activity
Organizational footprint4 full-time, 3 part-time employees (Q3 disclosure) Similar small team structure (Q2) Reaffirmed low burn/lean team (PR comments) Stable/lean

Management Commentary

  • CEO (AL001 readiness): “We strongly believe that AL001’s patented ionic cocrystal technology could potentially provide clinicians with a major improvement over current lithium-based treatments... We look forward to reporting topline data in June 2023...” .
  • CEO (pipeline confidence): “We strongly believe that AL001’s patented ionic cocrystal technology and the ALZN002 patient-specific immunotherapeutic vaccine candidate have the potential of treating over 40 million American...” .
  • CFO (liquidity path): “We expect to receive $14.8 million of cash in 2023... While no assurances can be given... the receipt... would be non-dilutive, and we anticipate utilizing such capital to file INDs... and conducting Phase II clinical trials...” .

Q&A Highlights

  • No Q3 2023 earnings call transcript was found in company documents; key topics and clarifications are drawn from the 8-K press release and 10-Q filings .

Estimates Context

  • Wall Street consensus EPS and revenue estimates for Q3 2023 via S&P Global were not available to retrieve during this session (request limit exceeded). As such, we cannot provide a beat/miss comparison relative to consensus at this time [GetEstimates error].

Key Takeaways for Investors

  • Near-term catalysts: AL001 Phase IIA topline (June 2023) and ALZN002 Phase I/IIA initiation (March 2023) can drive narrative and financing optionality even without revenue .
  • Expense-driven inflection: Elevating R&D to $2.89M in Q3 indicates accelerated clinical execution; monitor the pivot to Phase II designs and the impact on cash runway .
  • Liquidity watch: $7.38M cash at Q3 and potential $14.8M non-dilutive receivable by year-end (not assured) are critical to sustaining multi-indication expansion (BD, MDD, PTSD) .
  • Binary data event risk: AL001 Phase IIA topline will shape regulatory path and partnering prospects; positive safety/tolerability/PK outcomes could de-risk future trials .
  • Lean operating model: Small team with high external spend suggests scalability through outsourcing; assess dilution risks if receivable falls through and additional capital is required .
  • No revenue/margin framework yet: Trading thesis remains clinical and financing-driven until efficacy and commercialization visibility emerge; track IND filings and dose-finding progress .
  • Regulatory milestones: ALZN002 “study may proceed” and Phase I/IIA start bolster platform credibility; cross-indication AL001 plans expand TAM if clinical benefit supports broader mood disorder use .